Diagnostic Consumables Engineer

Organization
Cepheid - US
Job Location
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Sunnyvale, CA 94089
Salary
DOE
Job Description

As a Diagnostic Consumables Engineer, you will be a part of a fast-pace, multi-disciplines, and creative team that drive new product development and implement continuous improvements to new and existing processes. The ability to develop products, trouble-shoot, define root cause, provide resolution, and implement the necessary changes efficiently in an FDA regulated environment is critical. The ability to identify problem and create a solution through research and solid technical principles/disciplines is necessary.

Responsibilities:

In support of New Product Introduction (NPI) efforts, work with design engineers to optimize design drawings and supplier manufacturing processes so that high quality parts are consistently delivered.

  • Create and develop new invasive and noninvasive medical device product(s) from initial design to market and manufacturing release.
  • Hands on experience with validations, design for manufacture (DFM), material selection, and process development.
  • Conduct feasibility studies of the design to determine ability to function as intended.
  • Coordinate and drive new and existing consumable part and process qualifications from inception through completion in accordance with FDA and ISO guidelines.
  • Maintain detailed documentation throughout all phases of development through manufacturing.
  • Develop and document business practices, processes, procedures, and work instructions
  • Determine and execute the most appropriate testing to address process and system level performance issues involving cartridge consumables.
  • Lead technical aspects of Problem Solving, Failure Analysis, and Corrective and Preventative Actions with suppliers.
  • Promote a culture of structured problem solving.
  • Assist suppliers in developing final test requirements to ensure products meet specifications.

 

 

 

  • Bachelor's degree in Engineering plus 5 years of related work experience with a good understanding of specified functional area, or Master's degree in engineering with 1-2 years of related work experience, or an equivalent combination of education and work experience.
  • Experience with manufacturing processes, including machining, molding, ultrasonic welding.
  • Experience with GDT (Geometric Dimensioning and Tolerancing), quality measurement technique and use of SolidWorks.
  • Solid mathematical skills with basic statistics knowledge.
  • Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
  • May lead a project team of moderate scope. Provide guidance to less experienced staff.
  • Work under general supervision. Follow established procedures. Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.
  • Working knowledge of design of experiments (DOE) and interpretation of test results
  • Excellent communication skills. Must be able to communicate verbally in an efficient and effective and be proficient manner.
  • Knowledge of the ISO 9001, EN 13485, EN ISO 14971 , 21CFR 820 and ANSI-Y14.5 standards.

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How to Apply

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